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Evaluation of the Effect on Glucose Control and Safety of AC2993 in Patients With Type 2 Diabetes Treated With Metformin, Sulfonylurea, or Metformin and Sulfonylurea Combination

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
Hungary
Study Type
Interventional
Intervention
AC2993
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring exenatide, exendin-4, diabetes, Amylin, Lilly

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects with type 2 diabetes Treated for at least 3 months prior to screening either with metformin, sulfonylurea, or metformin and sulfonylurea combination BMI 25-45 kg/m^2 HbA1c between 7.5 % and 12.0 %, inclusive Exclusion Criteria: Treated with other oral anti-diabetic agents other than metformin and sulfonylureas within 3 months of screening Patients previously treated with AC2993 Patients presently treated with insulin

Sites / Locations

  • Diagnostic Units Hungary Kft.
  • Peterfy Teaching Hospital
  • Uzsoki Street Municipal Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AC2993

Arm Description

5 μg AC2993, twice daily, for 4 weeks followed by 10 μg AC2993, twice daily, during a maintenance period

Outcomes

Primary Outcome Measures

Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 24, Week 52, and to each intermediate visit
Change in HbA1c from Baseline to Week 24, Week 52, and to each intermediate visit (Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)
Change in concentrations of fasting plasma glucose and lipids from Baseline Visit 2 (Day 1) to Week 24, to Week 52, and to each intermediate visit
Change in concentrations of fasting plasma glucose and lipids from Baseline Visit 2 (Day 1) to Visit 10 (Week 24), to Visit 14 (Week 52) and to each intermediate visit (Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)

Secondary Outcome Measures

Full Information

First Posted
September 3, 2002
Last Updated
February 19, 2015
Sponsor
AstraZeneca
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00044668
Brief Title
Evaluation of the Effect on Glucose Control and Safety of AC2993 in Patients With Type 2 Diabetes Treated With Metformin, Sulfonylurea, or Metformin and Sulfonylurea Combination
Official Title
An Open-Label Study to Examine the Long-Term Effect on Glucose Control (HbA1c) and Safety of AC2993 Given Two Times a Day to Subjects With Type 2 Diabetes Treated With Metformin, a Sulfonylurea, or Metformin and Sulfonylurea Combination
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
September 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This multi-center, open-label study is designed to examine the effects on long-term glucose control and safety of AC2993 in patients with type 2 diabetes treated with metformin, sulfonylurea, or metformin and sulfonylurea combination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
exenatide, exendin-4, diabetes, Amylin, Lilly

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
155 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AC2993
Arm Type
Experimental
Arm Description
5 μg AC2993, twice daily, for 4 weeks followed by 10 μg AC2993, twice daily, during a maintenance period
Intervention Type
Drug
Intervention Name(s)
AC2993
Other Intervention Name(s)
synthetic exendin-4
Intervention Description
Subjects will receive 5 μg AC2993, subcutaneously injected twice daily, for 4 weeks followed by 10 μg AC2993, subcutaneously injected twice daily, during a maintenance period that is expected to continue for at least 11 months.
Primary Outcome Measure Information:
Title
Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 24, Week 52, and to each intermediate visit
Description
Change in HbA1c from Baseline to Week 24, Week 52, and to each intermediate visit (Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)
Time Frame
Baseline, and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Title
Change in concentrations of fasting plasma glucose and lipids from Baseline Visit 2 (Day 1) to Week 24, to Week 52, and to each intermediate visit
Description
Change in concentrations of fasting plasma glucose and lipids from Baseline Visit 2 (Day 1) to Visit 10 (Week 24), to Visit 14 (Week 52) and to each intermediate visit (Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)
Time Frame
Baseline, and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects with type 2 diabetes Treated for at least 3 months prior to screening either with metformin, sulfonylurea, or metformin and sulfonylurea combination BMI 25-45 kg/m^2 HbA1c between 7.5 % and 12.0 %, inclusive Exclusion Criteria: Treated with other oral anti-diabetic agents other than metformin and sulfonylureas within 3 months of screening Patients previously treated with AC2993 Patients presently treated with insulin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Porter, MD
Organizational Affiliation
Amylin Pharmaceuticals, LLC.
Official's Role
Study Director
Facility Information:
Facility Name
Diagnostic Units Hungary Kft.
City
Budapest
ZIP/Postal Code
H 1036
Country
Hungary
Facility Name
Peterfy Teaching Hospital
City
Budapest
ZIP/Postal Code
H 1076
Country
Hungary
Facility Name
Uzsoki Street Municipal Hospital
City
Budapest
ZIP/Postal Code
H 1145
Country
Hungary

12. IPD Sharing Statement

Citations:
PubMed Identifier
22608106
Citation
Ivanyi T, Fovenyi J, Faludi P, Han J, Macconell L, Wille S, Kiljanski J. Long-term effects of adding exenatide to a regimen of metformin and/or sulfonylurea in type 2 diabetes: an uncontrolled, open-label trial in Hungary. Clin Ther. 2012 Jun;34(6):1301-13. doi: 10.1016/j.clinthera.2012.04.022. Epub 2012 May 16.
Results Reference
derived
PubMed Identifier
22236356
Citation
Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10.
Results Reference
derived

Learn more about this trial

Evaluation of the Effect on Glucose Control and Safety of AC2993 in Patients With Type 2 Diabetes Treated With Metformin, Sulfonylurea, or Metformin and Sulfonylurea Combination

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